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Label indication Epinephrine injection is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants), and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media), and other allergens, as well as idiopathic…
Also known as Epinephrine autoinjector single dose
Epinephrine · 1 trial · 1 indication
Severity grading system for acute allergic reactions. Skin system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021
Severity grading system for acute allergic reactions, mucosal system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021
Severity grading system for acute allergic reactions, gastrointestinal system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021.
Severity grading system for acute allergic reactions, respiratory system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021.
Severity grading system for acute allergic reactions, Combined systems, anaphylaxis score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021.
Systolic and diastolic blood pressure by a blood pressure cuff
heart rate by pulse rate measurement
% oxygen saturation measurement using oxygen monitor
| Arm | Type | Description |
|---|---|---|
| FMXIN002 4mg + saline IM | EXPERIMENTAL | Epinephrine powder nasal spray together with a placebo IM injection |
| Adrenaline 0.5mg IM + placebo nasal spray | ACTIVE_COMPARATOR | Epinephrine IM injection together with a placebo nasal spray |
| Name | Type | Description |
|---|---|---|
| Epinephrine 4mg nasal powder spray | COMBINATION_PRODUCT | Epinephrine nasal powder spray in a unidose nasal applicator device. Will be administered together with a placebo saline IM injection |
| Adrenalin 0.5mg Injectable Product | COMBINATION_PRODUCT | Epinephrine 0.5mg for IM injection. Will be administered together with a placebo nasal powder spray. |
Inclusion Criteria: * Age 18-40 years, any gender * Documented or suspected food allergy (based on IgE level or clinical history) * Development of Grade II or III reaction during OFC Exclusion Criteria: * Age \<18 or \>40 * Poorly controlled asthma (FEV1 \< 80% or frequent symptoms) * Active eosi...
Epinephrine is used to treat anaphylaxis, a severe and potentially life-threatening allergic reaction. Nasus Pharma Ltd. is developing a nasal powder formulation for patients at risk of anaphylaxis triggered by food. This investigational product is in Phase 2 clinical development.
Epinephrine targets the alpha-1A, alpha-2A, alpha-2C, alpha-1D, beta-1, and beta-2 adrenergic receptors (ADRA1A, ADRA2A, ADRA2C, ADRA1D, ADRB1, ADRB2). It acts as an agonist at these receptors, which are part of the adrenergic receptor family.
Nasus Pharma Ltd. is developing Epinephrine. The company trades under the ticker symbol NSRX. Nasus Pharma is focused on developing a nasal powder spray formulation of epinephrine for anaphylaxis.
Epinephrine is in Phase 2 clinical development. It is an investigational product and has not been approved by the FDA for the indications being studied. The Phase 2 trial is currently enrolling by invitation.
Epinephrine is being studied in a Phase 2 clinical trial, NCT07045701, titled FMXIN002 in Patients at Risk of Anaphylaxis. The trial is enrolling 30 adult patients with food-triggered anaphylaxis in Israel. It is randomized, double-blind, and active-controlled.